s9628 dexamethasone plus interferon alfa in treating patients with primary systemic amyloidosis

Conditions: Multiple Myeloma

Summary: rationale: chemotherapy plus interferon alfa may be effective for primary systemic amyloidosis. purpose: phase ii trial to study the effectiveness of dexamethasone plus interferon alfa in treating patients who have primary systemic amyloidosis.

objectives: * evaluate m protein and organ dysfunction responses and overall and progression-free survival in patients with primary systemic amyloidosis treated with dexamethasone/interferon alfa. * identify prognostic factors that may relate to response and overall survival in these patients. * evaluate the qualitative and quantitative toxic effects of this regimen. outline: patients are stratified by prior amyloidosis treatment (yes vs no). all patients receive induction therapy with oral dexamethasone on days 1-4, 9-12, and 17-20 every 35 days for a total of 3 courses. maintenance therapy begins within 5-8 weeks (within 10 weeks if patients undergo stem cell harvest) of initiation of the third course of induction, as follows: oral dexamethasone for 4 days every 4 weeks; and subcutaneous interferon alfa 3 times per week. patients who achieved less than a 50% reduction in serum m protein or urinary bence-jones protein and who experienced less than grade 3 toxicity during induction receive 3 additional courses of pulse dexamethasone concurrently with entry to maintenance therapy and the initiation of interferon alfa. combination therapy is continued until 2 years from entry; thereafter, interferon is administered alone for at least 3 years, toxicity permitting. patients with stable disease after 5 years of therapy may discontinue interferon alfa at the discretion of the treating physician. patients are followed every 6 months for 2 years and yearly thereafter. projected accrual: a total of 100 patients (50 with prior melphalan/prednisone or iododoxorubicin treatment and 50 without) will be entered over 3 years.

Eligibility criteria:
disease characteristics: * histologically diagnosed primary systemic amyloidosis based on the following: * deposition of fibrillary protein with congo red positive stain or characteristic electron microscopic appearance * monoclonal light chain protein (bence-jones protein) in serum or urine or immunohistochemical studies * evidence of tissue involvement other than carpal tunnel syndrome * diagnostic histologic material available for central pathology review * confirmation of tissue diagnosis at all sites of organ dysfunction encouraged * no senile, secondary, localized, dialysis-related, or familial amyloidosis * no known therapy-related myelodysplasia patient characteristics: age: * adult performance status: * swog 0-4 hematopoietic: * not specified hepatic: * not specified renal: * not specified cardiovascular: * no nyha class iv status other: * no uncontrolled diabetes * no active peptic ulcer disease * no medical condition that precludes high-dose steroids * no second malignancy within 5 years except: * adequately treated nonmelanomatous skin cancer * in situ cervical cancer * adequately treated stage i/ii cancer in complete remission * not pregnant or nursing * effective contraception required of fertile patients * blood/body fluid analyses within 14 days prior to registration * imaging/exams for tumor measurement within 28 days prior to registration * other screening exams within 42 days prior to registration prior concurrent therapy: biologic therapy * no prior interferon alfa chemotherapy * prior melphalan allowed, but recovered from effects * at least 4 weeks since cytotoxic therapy and recovered endocrine therapy * prior prednisone allowed, but recovered from effects * at least 4 weeks since prior glucocorticoids * no prior dexamethasone * no planned or concurrent dexamethasone or other therapy for primary systemic amyloidosis radiotherapy * not specified surgery * not specified

Keywords: primary systemic amyloidosis